Bio-Tenodesis™ Screw System
The Bio-Tenodesis Screw System eliminates transosseous tunnels in
tendon repairs and ligament reconstructions. The Tenodesis Screw
may be used in conjunction with #2 or 2-0 FiberWire® to facilitate
intraoperative tissue tensioning and fixation in a predrilled socket.
The predrilled socket minimizes incision length, dissection, and
overall morbidity. PLLA or titanium Tenodesis Screw insertion provides
superior and immediate fixation for foot and ankle indications such
as Achilles repair, FDL, FHL tendon transfers and lateral ligament
stabilization. The system can also be used for applications in the hand
and elbow (UCL, LRTI, distal biceps), shoulder (rotator cuff repair,
proximal biceps) as well as collateral ligament repair/reconstruction
and secondary graft or suture fixation for ACL/PCL reconstruction.
This construct allows for direct tendon-to-bone healing, without
hardware prominence.
Consider These Surgical Procedures:
Knee:
Lateral and Medial Collateral Ligament Repair and
Secondary Fixation of an ACL Soft Tissue Graft
Foot and Ankle:
Achilles, Lateral Stabilizations and FDL,
FHL Tendon Transfers
Hand:
Ligament Reconstruction Tendon
Interposition (LRTI)
Elbow:
UCL and Distal Biceps Tendon Repair
Shoulder:
Proximal Biceps Tendon Repair and Rotator Cuff Repair
Surgical Technique:
T
Tendon
or Graft Fixation
An anatomic attachment site is determined and a 2.4 mm guide pin is inserted
with a power drill. A bone socket is created to a depth 2 mm longer than the
screw used. The tendon graft is anatomically tensioned over the socket and a
methylene blue line drawn on the tendon at the inner socket rim to mark the
appropriate tensioned graft length. The appropriate screw is inserted onto the
Tenodesis Driver and a FiberWire Loop is positioned around the tendon the length
of the screw away from the methylene blue mark (a). The extended Tenodesis
Driver tip is inserted into the socket with the graft end until the methylene blue
mark lies over the socket rim (b). The screw is inserted maintaining tension on
the graft. After full insertion of the screw, the driver is removed and graft passing
sutures exiting the screw/socket interface are tied with the FiberWire loop exiting
the screw cannulation over the screw rim as additional fixation (c). (Please use the
reference chart below to help select the appropriate implant, driver and diameter
for the reamed socket).
(a)
(b)
4 mm
4.75 mm 4.75 mm 5.5 mm
titanium titanium
5.5 mm
6.25 mm
7 mm
8 x 12 mm
8 mm
9 mm
Actual Sizes of Bio-Tenodesis Screws
(c)
Suggested Reference Chart
Graft
Diameter
Implant
Diameter
Implant
Length
Catalog
Number
Drill
Depth
Drill
Diameter
3 - 4 mm
4 mm
10 mm
AR-1540B
12 mm
4 - 4.5 mm
2-0
AR-1540DB
3.5 - 4.5 mm
4.75 mm
15 mm
AR-1547B
17 mm
4.5
5 - 5.5 mm
#2
AR-1350D
A
4.5 - 5.5 mm
5.5 mm
15 mm
AR-1555B
17 mm
5.5 - 6.5 mm
#2
AR-1350D
5 - 6 mm
6.25 mm
15 mm
AR-1562B
17 mm
6 - 7 mm
#2
AR-1350D
4.5 - 7 mm
7 mm
23 mm
AR-1570B
25 mm
7 - 8 mm
#2
AR-1570DB
5.5 - 8 mm
8 mm
12 mm
AR-1680B
14 mm
8 - 9 mm
#2
AR-1670DB
5.5 - 8 mm
8 mm
23 mm
AR-1580B
25 mm
8 - 9 mm
#2
AR-1570DB
7 - 9 mm
9 mm
23 mm
AR-1590B
25 mm
8 - 10 mm
#2
AR-1570DB
Implant diameter should be as close to graft diameter as possible by measuring 0 - 25 mm from the tip of the tendon.
Drill diameter should be 0.5 - 1 mm larger than tendon diameter, assuming the screw selected is within
1 mm of the tendon diameter.
Drill depth should be 2 mm longer than the length of the screw selected.
Drill selection is based on diameter size of tendon and quality of bone.
Suture
Loop
Driver Part
Number
Nitinol suture
passing wire
(a)
Creation of the FiberWire Suture Loop
The surgeon must create a FiberWire loop at the tip of the driver to
snare the tendon to be placed in the bone tunnel. The FiberWire
loop is created by a disposable nitinol suture passing wire and
#2 FiberWire found in the Bio-Tenodesis Disposable Kit (a). Snare the
tip of the whipstitched tendon 2 mm from the end of the graft (b). Place
tension on the sutures exiting the back of the Tear Drop Handle and
wrap them once around the o-ring inside the cleat as shown below (c).
It is important to maintain maximum tension between the driver tip
and the tendon during initial placement of the tendon in the tunnel.
FiberWire
loop
FiberWire
whipstitch
(b)
Strongest Fixation Strength
The chart below demonstrates the average pull-to-failure force of
Arthrex Bio-Tenodesis Screw compared to the Mitek GII anchor. The
testing was performed to determine the mechanical strength of fixation
of a biceps tendon by the Bio-Tenodesis Screw in a bone socket. The
Bio-Tenodesis Screw fixation of the biceps tendon was inserted into a
socket in the proximal humerus in cadaveric bone. The results indicate
that Bio-Tenodesis Screws behave in a mechanically superior fashion
when compared to the Mitek GII anchors (52 lbs vs. 30 lbs).
60
50
52 lbs.
Arthrex
Bio-Tenodesis
Screw,
7 mm
40
(c)
30
20
30 lbs.
Mitek GII
Suture Anchor
10
0
Average Load to Failure
*Data on file
Suture cleat
Bio-Tenodesis Screw System Implants, sterile, single use:
Bio-Tenodesis Screw, 4 mm x 10 mm
Bio-Tenodesis Screw, 4.75 mm x 15 mm
Tenodesis Screw, titanium, 4.75 mm x 15 mm
Tenodesis Screw, titanium, 5.5 mm x 15 mm
Bio-Tenodesis Screw, 5.5 mm x 15 mm
Bio-Tenodesis Screw, 6.25 mm x 15 mm
Bio-Tenodesis Screw, 7 mm x 23 mm
Bio-Tenodesis Screw, 8 mm x 23 mm
Bio-Tenodesis Screw, 9 mm x 23 mm
Bio-Tenodesis Screw, 8 mm x 12 mm
AR-1540B
AR-1547B
AR-1350-475
AR-1350-55
AR-1555B
AR-1562B
AR-1570B
AR-1580B
AR-1590B
AR-1680B
Bio-Tenodesis Master Instrument Set (AR-1675S) includes:
Tear Drop Handle w/Suture Cleat
Cannulated Drill, 4 mm
Cannulated Drill, 4.5 mm
Cannulated Headed Reamer, 5 mm
Cannulated Headed Reamer, 5.5 mm
Cannulated Headed Reamer, 6 mm
Cannulated Headed Reamer, 6.5 mm
Cannulated Headed Reamer, 7 mm
Cannulated Headed Reamer, 7.5 mm
Cannulated Headed Reamer, 8 mm
Cannulated Headed Reamer, 8.5 mm
Cannulated Headed Reamer, 9 mm
Cannulated Headed Reamer, 10 mm
Driver for 10 mm long Bio-Tenodesis Screw
Driver for 12 mm long Bio-Tenodesis Screw
Driver for 15 mm long Bio-Tenodesis Screw
Driver for 23 mm long Bio-Tenodesis Screw
Bio-Tenodesis Screw Instrumentation Case
AR-2001BT
AR-1204L
AR-1204.5L
AR-1405
AR-1405.5
AR-1406
AR-1406.5
AR-1407
AR-1407.5
AR-1408
AR-1408.5
AR-1409
AR-1410
AR-1540DB
AR-1670DB
AR-1350D
AR-1570DB
AR-1675C
Bio-Tenodesis Disposables Kit (AR-1675DS), sterile, qty. 5, single use:
i
includes
one each of the following:
Drill Tip Guide Pin, 2.4 mm
Suture Passing Wire
#2 FiberWire, 38 inches (blue) w/Tapered Needle,
26.5 mm 1/2 circle
#2 TigerWire, 38 inches (white/black)
2-0 FiberWire, 18 inches (blue) w/Tapered Needle,
17.9 mm 3/8 circle
2-0 FiberWire, 38 inches (blue)
AR-1250L
AR-1255-18
AR-7200
AR-7203
AR-7220
AR-7221
Optional Disposable Accessories:
FiberSnare, #2 FiberWire, 26 inches with closed loop,
one end stiff
stiffened, 12 inches
AR-7209SN
Optional Bio-Tenodesis Instrument Accessories:
Bio-Tenodesis Drill Guide, 4 mm/5.5 mm
Bio-Tenodesis Drill Guide, 5 mm/6.5 mm
Bio-Tenodesis Drill Guide, 4.5 mm/6 mm
Bio-Tenodesis Screw Drill, 4 mm
Bio-Tenodesis Screw Drill, 4.5 mm
Bio-Tenodesis Screw Drill, 5 mm
Bio-Tenodesis Screw Drill, 5.5 mm
Bio-Tenodesis Screw Drill, 6 mm
Bio-Tenodesis Screw Drill, 6.5 mm
U.S. PATENT NO. 6,544,281
AR-1542
AR-1543
AR-1544
AR-1204D
AR-1204.5D
AR-1205D
AR-1205.5D
AR-1206D
AR-1206.5D
Arthrex, Inc.
1370 Creekside Boulevard, Naples, Florida 34108-1945 • USA
Tel: 239-643-5553 • Fax: 239-598-5534 • Website: www.arthrex.com
Arthrex GmbH
Liebigstrasse 13, D-85757 Karlsfeld/München • Germany
Tel: +49-8131-59570 • Fax: +49-8131-5957-631
Arthrex Latin América
3750 NW 87th Avenue, Miami, Florida 33178 • USA
Tel: 954-447-6815 • Fax: 954-447-6814
Arthrex S.A.S.
5 Avenue Pierre et Marie Curie, 59260 Lezennes • France
Tel: +33-3-20-05-72-72 • Fax: +33-3-20-05-72-70
Arthrex Canada
Lasswell Medical Co., Ltd., 405 Industrial Drive, Unit 21, Milton, Ontario • Canada L9T 5B1
Tel: 905-876-4604 • Fax: 905-876-1004 • Toll-Free: 1-800-224-0302
Arthrex GesmbH
Triesterstrasse 10/1 • 2351 Wiener Neudorf • Austria
Tel: +43-2236-89-33-50-0 • Fax: +43-2236-89-33-50-10
Arthrex BvbA
Mechelsesteenweg 23, 2540 Hove • Belgium
Tel: +32-3-2169199 • Fax: +32-3-2162059
Arthrex Ltd.
Unit 16, President Buildings, Savile Street East, Sheffield S4 7UQ • England
Tel: +44-114-2767788 • Fax: +44-114-2767744
Arthrex Hellas - Medical Instruments SA
43, Argous Str. - N. Kifissia, 145 64 Athens • Greece
Tel: +30/210/8079980 • Fax: +30/210/8000379
U.S. PATENT NO. 6,544,281
©Copyright Arthrex Inc., 2004. All rights reserved. LB0505C